Dr Zoltán ERDŐS Qualiment Ltd.

, Budapest

S S
R E
N G
CO
O Q IMPROVEMENT OF INTEGRATED
tE
51
s MANAGEMENT SYSTEMS:

IMPLEMENTATION
OF ISO 22000 BASED HA
RA
FOOD SAFETY P
UE
MANAGEMENT
AG
PR
07
20
1
FOOD SAFETY IN PRAXIS traditional h is
tory

CRITICAL CONTROL POINTS

HACCP REGULATION
CONTROL MEASURES INCLUDED IN HACCP

some additive regulations,

mostly incorporated to HACCP manual

FUNDAMENTAL HYGIENE
(often without documented rules)
BASIC MEASURES, GMP / GHP, „§”

2
FOOD SAFETY IN PRAXIS in progress ea rs
5 y
l a st

CRITICAL CONTROL POINTS

HACCP REGULATION
CONTROL MEASURES INCLUDED IN HACCP

ADDITIVE HYGIENIC and

FOOD SAFETY REGULATIONS ,
like SSOP’s, CUSTOMER REQUIREMENTS etc.

FUNDAMENTAL HYGIENE
(partialy documented rules - e.g. personal hygiene)
BASIC MEASURES, GMP / GHP D

3
 no
FOOD SAFETY IN PRAXIS ISO 22000 w

CRITICAL CONTROL POINTS CCP

HACCP REGULATION
HACCP PLANS - CCP’s

FOOD SAFETY REGULATIONS:

OPERATIONAL PRP’S op PRP
FOOD SAFETY CONTROL PROCEDURES

FUNDAMENTAL HYGIENE, PRP

BEST KNOWLEDGE, GMP / GHP,
CODEX ALIMENTARIUS GL’s - PRP’s D

4
 ! ! !

  

§ 





!
!

!










 ? GMP HA ISO
GMP GHP CCP 9001
GHP ISO
HACCP
9001

GMP HA ISO
Quality management system
GHP CCP 9001

HA ISO
Food safety management system + GHP
9001
( IFS, BRC ) CCP

+ = REQUIREMENTS of
RETAILER CHAINS GMP op HA ISO
ISO
+ GHP
Food safety management system (PRP) PRP CCP 9001
9001
( ISO 22000 )

ISO 22000
Integrated ISO 14001 ISO 9001
management
system
 analysis of
operational steps

environment
Origin of raw
materials

process
Process:

personnel

Step / No.:

actual step
Preceding
member
of food chain

Preceding Following
steps steps

Preceding Next processes

processes

Equipment Related by-processes Added components Next member Utilizer

Tools Linked processes of food chain Consumer
Final consumption
= influence
 HAZARD ANALYSIS

Planning and FOOD SAFETY TEAM

production of safe PRODUCT DESCRIPTION

a
products PRP INTENDED USE

PROCESS FLOW DIAGRAM

Process analysis STEPS AND SAFETY MEASURES

Hazard analysis HAZARDS, ACCEPTED .LEVELS

Risk assessment HAZARD & RISK ASSESSMENT b

SELECTION OF CONTROL MEASURES

op PRP CCP
HACCP c
VALIDATION OF MEASURES

d
PLANNING OF VERIFICATION

8
 HAZARD ANALYSIS

PRP op PRP CCP

ENVIRONMENT, OPERATION, CRITICAL POINT,

RESOURCES, PROCESS process STEPS
BASIC HYGIENE
CONTROL, CRITICAL
TARGET LIMITS
PARAMETERS

CONTROL INTERVENTION
9
 IDENT.OF HAZARDS, DECISION TREE
ACCEPTED LEVELS
ISO 22000
RISK ASSESSMENT:
PROBABILITIES

ELIMINATION IS N CONTROL MEASURE

NECESSARY? NOT REQUIERED
Y
CONTROL IS N CONTROL MEASURE
NECESSARY? NOT REQUIERED
Y
COMBINATION OF
CONTROL MEASURES

VALIDATION OF CONTROL
MEASURE COMBINATIONS

CATEGORIZATION

op PRP CCP 10
 HAZARD ANALYSIS

DECISION TREE
METHOD EXISTS? N
HACCP

Y Y
STEP FOR ELIMINATION CCP
OF HAZARD ?
N
N
EXCEEDING no CCP
OCCURES ?
Y
Y
CONTROLLED BY no CCP
OTHER STEP ?
N

CCP

„ Y… N …Y … N ”
11
 HAZARD ANALYSIS

DECISION TREE
METHOD
HAZARD
EXISTS?
? N
HACCP

Y Y
STEP FOR PREVENTION
ELIMINATION IS CCP
OF HAZARDNECESSARY?
?
N
N
EXCEEDING no CCP
OCCURES ?
Y
Y
CONTROLLED BY no CCP
OTHER STEP ?
Y
…or by OTHER N
PROGRAM ? op PRP

CCP „ Y… N …Y … Y ”

„ Y… N …Y … N ”
12
 HAZARD ANALYSIS

PRP op PRP CCP

ENVIRONMENT OPERATION CRITICAL POINT

RESOURCES PROCESS process STEPS
BASIC HYGIENE
CONTROLLED BY MONITERD BY
PROCESS MANAGER STEP OPERATOR
e.g. head of shift
P LE
X AM Y (nominated
(responsibility E L
ON
by position) responsibility)
documented by documented by
weekly signing daily signing
of a record sheet of a record cell

nonconformities reported in a log-book

13
 STEP OPERATOR

PROCESS MANAGER

signatures: „OK” satus

(responsibility !)

X marks or notes: „incident” satus

(to report !)

observations, nonconformities,
decisions, corerective actions
other measures ….

log-book
14
 P LE
managing director X AM adding
E new technology
or equipment

Valeria production director

? = ! 

Veronica Q manager Plant manager

X? =X!
Monica inspector Head of shift
xxyxxyyxy

15
 monitoring verification validation implementation

P LE
managing director X AM adding
E new technology
or equipment

Valeria production director

Validation ? = ! 

Veronica Q manager Plant manager

Verification X ? =X!
Monica inspector Head of shift
Monitoringxxyxxyyxy
Implementation
16
 EX
AM
P LE
managing director
continual use

Valeria production director

? = ! 

Veronica Q manager Plant manager

X? =X!
Monica inspector Head of shift
xxyxxyyxy

17
 implementation monitoring verification
EX
AM
P LE
managing director
continual use

Valeria production director

Management rewew
(Re)validation ? = ! 

Veronica Q manager Plant manager

Verification X ? =X!
Monica inspector Head of shift
Monitoringxxyxxyyxy
Implementation
18
 monitoring verification
EX
AM
P LE
managing director
continual use

Valeria production director

Management rewew
(Re)validation ? = ! 

Veronica Q manager Plant manager

Verification X ? =X!
Monica inspector Head of shift
Monitoringxxyxxyyxy

planned frequency 19
 ALIMIA Ltd. ISO 9001 + ISO 22000 basic documents

QUALITY MANUAL
FOOD SAFETY MANUAL

PROCEDURES

FOOD SAFETY ?

RECORDS
 ALIMIA Ltd. ISO 9001 + ISO 22000 basic documents

QUALITY MANUAL
FOOD SAFETY MANUAL

PROCEDURES

FOOD SAFETY
SUPPLEMENTS

RECORDS
 ALIMIA Ltd. ISO 9001 + ISO 22000 basic documents

QUALITY MANUAL
FOOD SAFETY MANUAL

PROCEDURES

FOOD SAFETY
SUPPLEMENTS
F.S. CONTROL DOCUMENTS

RECORDS
 ALIMIA Ltd. ISO 9001 + ISO 22000 basic documents

QUALITY MANUAL
FOOD SAFETY MANUAL

PROCEDURES

FOOD SAFETY
SUPPLEMENTS
F.S. CONTROL DOCUMENTS

RECORDS
 TOP MAMAGEMENT
INTEGRATED Company
Statute
MANAGEMENT
GENERAL PROCEDURES P-
SYSTEM

TRADITIONAL MANAGEMENT REGULATIONS

FUNCTIONAL MANAGEMENT SYSTEMS
( BUSINESS, PRODUCTION, TECHNICAL,
MARKETING, SALES ETC. )
MANUALS
QUALITY FOOD SAFETY HACCP ENVIRONM..

INFORMATICS.
CONTROLLING QP– HP – EP –
TQM
IMPROVEMENT FUNCTIONAL PROCEDURES (QP, ...)

TECHNOLOGICAL

TECHNICAL INSTRUCTIONS, CODES, PROF.DOCUMENTS

PROD.DEVELOPMENT
ENVIRONMT
QUALITY HYGIENE HACCP REGUL.
PURCHASING
PLANS,
SALES PRODUCTION, SSOP’S
TECHNOLOGY FOOD
MMARKETING
ŰV. DOK SANITATION
HUMAN RES.
( PRP )
OTHERS

R E C O R D S
 BRAIN FUNCTIONS,
ABILITIES

LOGICS IMAGE -
THINKING, MATHEMATICS PROCESSING CREATIVITY
EXECUTION STEP BY STEP INTUITION,
THINKING EMOTIONS
KNOWLEDGE EXPERIENCE
STRATEGY UNCONSCIOUS
(QUICK)
„BUSINESS”
THINKING
MANAGING
FUNCTIONS: EGO
QUICK , MANAGING
EXECUTION CONSCIOUS „INTUITIVE” FUNCTIONS:
REALIZATION DECISIONS DECISIONS PROBLEM-
FULFILMENT PLANING SOLVING
SENSORIC,
ABSTRACT, TOOLS:
EXACT
INSPIRATIVE
TOOLS: REALIZATION FUNCTIONS
FUNCTIONS
REGULATIONS RESPONSI-
INSTRUCTIONS BILITY

PRESCRIPTIONS + FREEDOM +
25
DIRECTION RESPONSIBILITY
THANK YOU !